Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain

21 mars 2019 mis à jour par: Jordan Miller, PT, PhD, Queen's University

Determining the Impact of a New Physiotherapist Led Primary Care Model for Back Pain: A Pilot Cluster Randomized Controlled Trial

This is a pilot cluster randomized controlled trial to determine the feasibility of a cluster randomized trial to evaluate the individual and health system impact of implementing a new physiotherapist-led primary care model for back pain in Canada.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with back pain. The primary purpose of this pilot study is to determine the feasibility including recruitment and retention of primary care teams (sites) and patient participants, carrying out the assessment procedures, and implementing the physiotherapist-led primary care intervention including training the physiotherapist to adopt this role.

Type d'étude

Interventionnel

Inscription (Réel)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 3N6
        • Queen's University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Adults (18 years and over) with back pain of any duration
  • Seeking primary care for back pain at a participating site
  • Primary care visit may be a first or repeat visit

Exclusion Criteria:

  • Patients who do not consent to participation
  • Patients who report being unable to understand, read, and write English

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Modèle de soins primaires dirigé par un physiothérapeute pour les maux de dos
Le modèle de soins primaires dirigé par le PT pour les maux de dos impliquera l'intégration d'un PT au sein de l'équipe de soins primaires au premier point de contact pour les personnes souffrant de maux de dos, sans frais pour le patient. Les patients de ce modèle auront le choix de consulter le physiothérapeute ou le médecin de famille. Ils seront encouragés à prendre rendez-vous avec le physiothérapeute, sauf lorsque la raison principale de la visite est le renouvellement des médicaments ou lorsque le patient a des problèmes de santé supplémentaires qui nécessitent l'attention de son médecin au cours de la même visite. Il y aura 4 éléments clés de l'intervention de soins primaires dirigée par le PT : 1) évaluation et dépistage initiaux ; 2) Brève intervention individualisée lors de la première visite; 3) Navigation dans les services de santé ; 4) Fournir des soins de physiothérapie supplémentaires aux personnes ayant un besoin non satisfait.
Comportemental: Physiotherapist-led primary care model for back pain
  1. Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination
  2. Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active.
  3. Health services navigation: PT assistance with navigating healthcare services based on the assessment findings. First, red-flags requiring emergency or urgent referrals. Next, comorbid conditions that would benefit from care from other healthcare providers. Finally, referral to PT (if appropriate).
  4. Providing additional physiotherapy care to people with an unmet need: Additional physiotherapy care will be provided to patients who have an identified need for physiotherapy but no physiotherapy coverage through private or government health insurance plans.
Comparateur actif: Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada. This usually includes a visit to a primary care physician, who would perform a history and physical examination, provide LBP education, and prescribe medications and/or refer based on their assessment findings and patient preferences.
Autre: Usual care
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Recruitment of primary care teams
Délai: Baseline
Ability to recruit four primary care teams (Family Health Teams or Community Health Centres) to paricipate
Baseline
Recruitment of patient participants
Délai: Baseline to 14 weeks
Recruitment rate (participants/week) or total number of participants recruited in 14 weeks
Baseline to 14 weeks
Assessment completion
Délai: Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
Percentage of all assessment items completed by participants completing each assessment
Baseline, 6-week 12-week, 6,9,12 month follow-up. The primary time point for this assessment is 12-week follow-up.
Retention of patient participants
Délai: Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
Attrition rate
Retention of participants at 6-week, 12-week, 6, 9, and 12-month follow-up assessments. The primary timeline for this outcome is 12-month follow-up.
Physiotherapist confidence in carrying out the interventions
Délai: Baseline
The PT will rate his/her confidence in each component of the intervention after the training on a scale from 0-10 with higher scores indicating greater confidence in carrying out that component of the intervention.
Baseline
Treatment fidelity
Délai: 6-week follow-up
Treatment fidelity will be measured by consistency with the intervention described in the protocol measured through an intervention checklist completed by the physiotherapist and an audit of the EMR notes.
6-week follow-up

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Self-reported disability
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the Roland Morris Disability Questionnaire (0 to 24 with higher scores indicating greater disability)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Self-reported pain intensity
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity (measured at rest, during walking, and during a lifting task)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health Related Quality of Life
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Global rating of change
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning related to back pain and positive scores indicating an improvement of physical functioning related to back pain)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Satisfaction with health care
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an 11-point scale(-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Catastrophic Thinking
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Depressive symptoms
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using the 9-item Patient Health Questionnaire (PHQ-9) (0 to 27 with greater scores indicating increased depressive symptoms)
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Adverse events
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
measured using an adverse events questionnaire that asks 1) if the patient has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Percentage of patients receiving care within 48 hours.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care accessibility
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Percentage of patients who score medium or high risk on the STarT Back tool who receive physiotherapy care.
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Health care utilization
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
All health care visits (aggregated and dis-aggregated) including: primary care visits, emergency department visits, hospitalizations, surgeries, consultations with other health care providers, diagnostic imaging, medications, and other care received by the patient
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Costs (piloted for a cost utility analysis in a future trial)
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Includes all health care costs plus societal costs using a human capital approach for loss of productivity
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Medications prescribed
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Diagnostic imaging ordered
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
referrals to other health care providers made
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
notes made by primary care provider to employers or insurers
Délai: Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up
Measured as a process outcome
Baseline, 6-week, 12-week, 6-month, 9-month, and 12-month follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Queen's University

Collaborateurs

Canadian Institutes of Health Research (CIHR)

Les enquêteurs

  • Chercheur principal: Jordan Miller, PhD, Queen's University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

20 septembre 2017

Achèvement primaire (Réel)

15 janvier 2019

Achèvement de l'étude (Réel)

15 janvier 2019

Dates d'inscription aux études

Première soumission

16 octobre 2017

Première soumission répondant aux critères de contrôle qualité

24 octobre 2017

Première publication (Réel)

25 octobre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 mars 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 mars 2019

Dernière vérification

1 mars 2019

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 6021536

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

There is no plan to share individual participant data from this pilot study. This data will be used to inform the protocol for a fully powered cluster randomized trial.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Mal au dos

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Mozambique

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

S'abonner